MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ALL POLY PATELLA CEMENTED 29 MM DIAMETER; PROSTHESIS, KNEE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 04/13/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent a manipulation under anesthesia approximately two months post implantation due to limited range of motion.No intraoperative complications were reported.There is no additional information available.

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated report: 3007963827-2023-00109; 3007963827-2023-00110; 3007963827-2023-00111.D10-medical product: femur cemented (ps) narrow right size 6 item# 42500006002 lot# 64729935; tibia cemented 5 degree stemmed right size d item# 42532006702 lot# 64805314; articular surface fixed bearing (cps) right 12 mm height item# 42522600512 lot# 64666743.Arthrofibrosis is defined as the development of fibrous scar tissue within or surrounding a joint.Arthrofibrosis is a known postoperative procedure related complication that can occur from surgical implantation of new joint replacement as well as from previous injuries or surgical procedures.Scar tissue formation is a normal healing response; however, the buildup of such can result in pain, stiffness, limited range of motion, and difficulty properly ambulating.If excess scar tissue develops, conservative measures such as exercises or physical therapy would be attempted first.If these attempts fail, surgical intervention such as manipulation under anesthesia, arthroscopic arthrolysis, or open arthrotomy would become necessary to remove the fibrous tissue and restore joint function.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ALL POLY PATELLA CEMENTED 29 MM DIAMETER
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16859986
• MDR Text Key: 314452065
• Report Number: 0002648920-2023-00085
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 00889024643697
• UDI-Public: (01)00889024643697(17)281116(10)64843522
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172524
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42540000029
• Device Lot Number: 64843522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White